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IRCT20141027019705N5 IRCT 2025-02-18 Arak University of Medical Sciences Investigation of traditional-Iranian medicine(Nigella sativa , Trigonella foenum- graecum, Rhus coriaria , Portulaca oleracea ) products on blood sugar in type II diabetic patients The effect of a traditional Iranian medicine product (fenugreek + black cumin + sumac + comfrey) on the control of blood sugar indicators in patients with type II diabetes compared to the placebo group 2025-04-04 anticipated 72 Complete https://irct.ir/trial/80694 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: People with type 2 diabetes are divided equally into two intervention and control groups. By stratified randomization based on BMI (between 20 and 25, between 25 and 30, and greater than or equal to 30), people are placed in two intervention and control groups. People are matched between the intervention and control groups based on BMI, Blinding description: First, the participants are informed about the study. This study is a triple-blind study. The two groups, the drug and the placebo, are given identical capsules. And they are unaware of the contents of the capsules. In addition, the investigator, the analysis unit and/or the DSMB (Data and Safety Monitoring Board) are unaware of the type of intervention they are assigned to. 3 Diabetes type 2. Intervention 1: Intervention group: The intervention group, under the supervision of a relevant specialist, in addition to common diabetes treatments, received 6 capsules daily containing 4 plants: black seed, fenugreek seeds, sumac, and purslane for 8 weeks. Intervention 2: Control group: Control group: The placebo group, in addition to common diabetes treatments, received 6 capsules containing Oisel daily for 8 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Privacy Protection: Protecting the privacy and security of participant information is our top priority. Even though the data are de-identified, we are concerned that it might still be possible to re-identify participants by combining this data with other sources.
public Mehdi Salehi
Arak university of medical science
Arak Iran (Islamic Republic of) 3818134638 +98 918 364 8352 m_salehi@razi.tums.ac.ir Arak University of Medical Sciences scientific Mehdi Salehi
Arak university of medical science
Arak Iran (Islamic Republic of) 3818134638 +98 918 364 8352 m_salehi@razi.tums.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Patients with type 2 diabetes FBS 2- Fasting blood sugar equal to or higher than 126 mg to 200 mg per deciliter or random sugar equal to or higher than 180 mg per deciliter HgbA1c: 6.5 to 9 - Use of oral hypoglycemic drugs (no insulin) No use of sulfonylurea drugs: Amaryl (Glimipride), Donil (Glibenclamide), Diamicron (Gilclazide), Minodiab (Glipizide), Tolbutamide, Tolazamide and glucocorticoids (Glipizide) Gilbenes Taking a fixed dose of oral hypoglycemic drugs for at least the past 3 months Not receiving enteral or parenteral nutrition Not pregnant or breastfeeding Individuals with a body mass index above 18.5 Not having kidney, liver, cardiovascular, thyroid or cancer disease aged 20 to 65 years old 20 years 65 years Both Having a specific disease that could interfere with the study process Allergy to the plants studied Following a special diet or taking supplements Using Oral contraceptive pill E08 Diabetes mellitus due to underlying condition Treatment - Drugs Placebo Intervention group: The intervention group, under the supervision of a relevant specialist, in addition to common diabetes treatments, received 6 capsules daily containing 4 plants: black seed, fenugreek seeds, sumac, and purslane for 8 weeks. Control group: Control group: The placebo group, in addition to common diabetes treatments, received 6 capsules containing Oisel daily for 8 weeks. Fasting blood glucose. Timepoint: Before the intervention begins and at the beginning of the study, all subjects will have their blood sugar levels measured. After 8 weeks of administering the intervention, all subjects will be retested using the same method and at the same initial location, and the results will be compared. Method of measurement: Fasting blood sugar is measured by enzymatic colorimetric method. Fasting insulin is measured by enzyme immunoassay method. The QUIKI index is used to calculate insulin sensitivity. To calculate the QUIKI index, fasting insulin is used in U/mlμ scale and fasting glucose is used in mg/dl scale: QUIKI = 1 / [log (FI) + log (FG)] To calculate insulin resistance, the HOMA-IR index is used. To calculate the HOMA-IR index, fasting insulin is used in U/lμ scale and fasting glucose is used in /l nmol scale: HOMA-IR = fasting insulin (μU/L) x fasting glucose (nmol/L)/22.5. Lipid profile. Timepoint: Before the intervention begins and at the beginning of the study, all individuals will be examined for their lipid profile, and after 8 weeks of administering the desired intervention, all individuals will be retested using the same method and at the same initial location for the second phase of testing, and the results will be compared. Method of measurement: Serum cholesterol, LDL, HDL, TG are measured by colorimetric enzymatic method. Liver enzume. Timepoint: Before the intervention begins and at the beginning of the study, all subjects' liver enzymes will be measured, and after 8 weeks of administering the desired intervention, all subjects will be retested using the same method and at the same initial location for the second phase of tests, and the results will be compared. Method of measurement: AST, ALT, and ALP are measured by the colorimetric method. Blood sugar indices. Timepoint: Before the intervention, that is, at the beginning of the study, patients will be evaluated for blood sugar. After 8 weeks from the start of the intervention, all individuals will be retested using the same method and at the same initial location for the second phase of tests, and the results will be compared. Method of measurement: At the beginning and end of the study, FBS (fasting blood sugar), and fasting insulin, were measured after a 12-hour fast and two indices QUIKI and HOMA-IR were calculated. FBS was measured by the enzymatic colorimetric method. Fasting insulin was measured by the enzyme immunoassay method. The QUIKI index was used to calculate insulin sensitivity. To calculate the QUIKI index, fasting insulin was used in the U/mlμ scale and fasting glucose was used in the mg/dl scale:QUIKI = 1 / [log (FI) + log (FG)]The HOMA-IR index was used to calculate insulin resistance. To calculate the HOMA-IR index, fasting insulin in U/lμ and fasting glucose in nmol/l are used: HOMA-IR = fasting insulin (μU/L) x fasting glucose (nmol/L)/22.5. Lipid profile indices. Timepoint: Before the intervention, that is, at the beginning of the study, patients will be evaluated for lipid profile. After 8 weeks from the start of the intervention, all individuals will be retested using the same method and at the same initial location for the second phase of tests, and the results will be compared. Method of measurement: At the beginning and end of the study, serum cholesterol, LDL, HDL, and TG are measured using the enzymatic colorimetric method. Liver functional enzymes. Timepoint: Before the intervention, that is, at the beginning of the study, patients will be evaluated for liver functional enzymes. After 8 weeks from the start of the intervention, all individuals will be retested using the same method and at the same initial location for the second phase of tests, and the results will be compared. Method of measurement: At the beginning and end of the study ALT, AST and Alp were measured after a 12-hour fast.. AST, ALT and ALP were measured by the colorimetric method. Arak University of Medical Sciences Approved 2024-12-01 The Research Ethics Committee of Arak University of Medical Sciences, Arak, Iran e of Arak University of Medical Sciences, Arak, Iran Arak Markazi Iran (Islamic Republic of)